BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AMER. HISTO-ID SYS PRIMARY KIT

    K Number: K842326 · Decision Aug 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    35
    Review Days
    50

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    Basic Information

    Device Name
    AMER. HISTO-ID SYS PRIMARY KIT
    K Number
    K842326
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Bartels Immunodiagnostic Supplies, Inc.
    Date Received
    June 13, 1984
    Decision Date
    August 2, 1984
    Product Code
    DFH
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DFH Kappa, Antigen, Antiserum, Control

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    Other Clearances by Bartels Immunodiagnostic Supplies, Inc.

    K Number Device Name
    K864776 A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS
    K861172 ROTAVIRUS LATEX AGGLUTINATION ASSAY
    K860279 CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
    K855034 AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT
    K842830 IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
    K852185 RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT
    K844105 FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY
    K842834 HEP-2 CELLS
    K842833 PMK PRIMARY MONKEY KIDNEY-CELLS
    K842328 AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN
    Search all 35 clearances from Bartels Immunodiagnostic Supplies, Inc. →